# BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER

> **NIH NIH N01** · SRI INTERNATIONAL · 2021 · $587,571

## Abstract

Within  the  Division  of  Intramural  Population  Health  Research  (DIPHR),  the  Contraceptive 
Development Program (CDP) at NICHD supports research to develop compounds that can disrupt normal 
ovulation, sperm production or sperm function for the purpose of developing safe, effective and  
affordable  contraceptives  for  men  or  women.    The  Biological  Testing  Facility  (BTF)  is 
designed  to  allow rapid evaluation of new compositions-of-matter,  drug formulations, delivery 
systems, and devices for contraceptive and endocrine activity.  The BTF provides overall project 
management  and  the  capabilities  to  support  all  phases  of  preclinical  activities  pursuant 
 to development of new contraceptive methods: these include, but are not limited to in vitro and in 
vivo  assays,  plasma  and  microsomal  stability  studies,  absorption,  distribution,  
metabolism, excretion and toxicity (ADMET), pharmacokinetic (PK) and pharmacodynamic (PD) 
profiling, animal activities and studies, manufacture of active pharmaceutical ingredients (APIs), 
process and  product development, formulation, clinical lot  production, preclinical  enabling 
studies and associated tasks leading to the filing of investigational new drug (IND) applications. 
Compounds formulated by the BTF are, or will be, tested in non-human primates.  NICHD maintains a 
colony of non-human primates for the purpose of evaluating potential contraceptive agents prior to 
trials in  human  subjects.   Compounds formulated  by the  BTF  that  are  prepared  under  
current Good Manufacturing Practices (cGMP) will allow clinical evaluation in the CDP Contraceptive 
Clinical Trials Network (CCTN). The CCTN investigators have develop protocols to evaluate the drug 
candidates identified as high priority by the Program. The BTF has been working with the CORs for  
the Chemical  Synthesis Facility  and  the CCTN  and  with  the investigators in  the CCTN  to 
develop and test the appropriate formulations for clinical batches of the candidate compounds. The 
next clinical study for each candidate drug is dependent on timely receipt of clinical batches to 
begin the process of recruitment and enrollment.   Drugs that are currently in ongoing clinical
of the clinical formulations.  The Biological Testing Facility plays a
critical role in the drug development mission of the CDP.

## Key facts

- **NIH application ID:** 10390264
- **Project number:** 75N94020D00003-P00001-759402000002-1
- **Recipient organization:** SRI INTERNATIONAL
- **Principal Investigator:** TOUFAN PARMAN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $587,571
- **Award type:** —
- **Project period:** 2020-09-04 → 2022-09-03

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10390264

## Citation

> US National Institutes of Health, RePORTER application 10390264, BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER (75N94020D00003-P00001-759402000002-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10390264. Licensed CC0.

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